The Minister of health, Kwaku Agyeman Manu, has expressed worries about the drug registration system in Africa that remains complex and varied with each country invoking separate audit and assessment processes, which mostly indicates that Africans will be the last to benefit from new drugs launched onto the international market.
According to Mr. Agyeman Manu, most of the National Medicines Regulatory Authorities (NMRAs), have limited capacity to approve medicines in a timely manner and to ensure acceptable quality, safety and efficacy standards.
However, he explained that, the absence of adequate technical capacity has been one of the reasons for this. Other factors have been resource constraints, different technical and administration requirements between countries and failure to leverage regulatory review activities which are performed by trusted and better resourced regulatory authorities.
He was speaking in an interview at the 3rd Biennial Conference on Medical Products Regulation in Africa dubbed “Sustaining the Momentum for Regulatory Harmonization in Africa”, organized by Penplusbytes (www.penplusbytes.org) in collaboration with the West African Health Organisation (WAHO) and with support from the Government of Ghana at Alisa Hotel, from 27 and 28 November 2017.
Mr. Agyeman Many indicated that, the subject of medical products regulation harmonisation has been on the drawing board for quite sometime and the initial assessments pointed out that, it takes as long as 4 years or more to get access to global health medicinal products in certain African countries.
Saying that, significant strides have been made over the years to enhance and modernize the regulation of pharmaceutical manufacturing and product quality across the world. However, Harmonisation of the processes for medicine registration, is long overdue.
Therefore, the objective of the African Medicines Regulatory Harmonisation Programme (AMRH) he said, is timely and a step in the right direction, as it seeks to establish and improve standards and requirements related to the regulation, access to safe and high-quality medicines for the African population.
According to the Health Minister, the idea of harmonisation was birthed out of the need to address these obstacles to access medicines in the region, to ensure quality and safety of medical products in the African region and as well prevent duplication of efforts by member states.
In the light of this, Mr. Agyeman Manu said, the African Medicine Regulatory Harmonisation (AMRH) initiative, was also set up with the vision to reduce the overall timelines for regulatory processes throughout the life cycle of products without compromising product safety, efficacy, good performance and quality.
He said again that, the strategy that this initiative sought to adopt, is to use the Economic Communities within the African continent to achieve the vision.
“I am aware of the challenges to the harmonisation process and the progress made so far. I encourage countries to open up a little bit more to this agenda as we move forward. I encourage us all to consolidate our efforts at leveraging on all fronts including language differences and differences in organisational structures and guidelines.” Mr. Agyeman Manu admonished.
“Harmonized good manufacturing practice (GMP) guidelines that is in place as well as joint inspections that are conducted for products filed under centralized procedure to be supplied throughout the East African Community (EAC) is worthy of note and commendation. As a result, 35 products were assessed at the end of 2016 using the centralized procedure and 8 products have had regulatory decision.
The adopted WHO GMP inspection standard for joint inspections coordinated by Zimbabwe and the corresponding MOU among ZAZIBONA countries ( Zambia, Zimbabwe, Botswana, Namibia) is facilitating the process of information exchange and confidentiality among ZAZIBONA. This has culminated in over 12 joint inspections conducted as at September 2016. I must say this is also commendable and the way to go,” the health Minister emphasised.
According to him, within the ECOWAS, a committee comprising representatives of all the 16 member states on Substandard and Falsified (SF) medicines and illicit trade on medicines in the sub-region has been actively set up.
Adding that, a draft legislative framework of SF and illicit trade in medicines has also been approved by the Council of Ministers of the ECOWAS region, and there has also been an agreement on a Common Technical Document (CTD) for medicine registration with technical support from WHO which is in the process of being validated this year.
“I also want to acknowledge the development of the Pharmacovigilance strategy and plans which is strategic for us in the region, to partner in clinical trials and drug development.
We are here today to evaluate the progress made so far and assess our current position and create a future for Africa Harmonisation program. We hope to be able to chart our way forward in these two days that we are all gathered here. Africa is rising and I trust together we can move forward.” He said.
The two-day event is the third of its kind and the first time it is being hosted in Ghana.
It aims to establish – in partnership with the African Union Commission and the World Health Organization – the African Medicines Agency, which will operate under the authority of AMRH. And the agency will also oversee the registration of a selected list of medicines and coordinate regional harmonisation systems on the continent.
The organizing Committee for the conference comprises; NEPAD Agency, the African Union Commission (AUC), the World Health Organization (WHO), National Medicines Regulatory Authorities (NMRAs), Regional Economic Communities (RECs) and Regional Health Organizations (RHOs), the International Federation for Pharmaceutical Manufacturers (IFPMA) and Associations and Federation of African Pharmaceutical Manufacturers Associations (FAPMA)
WHO who is responsible for providing technical support for implementation, NEPAD also responsible for political Advocacy, coordination and lesson-sharing across the Regional Economic communities and WORLD BANK manages the Trust Fund and the disbursement of funds to recipient organizations.
Development Partners (BMGF, DFID, US Govt.,GAVI, SDC), who have oversight for effective fund utilization.